MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02076906|
Recruitment Status : Recruiting
First Posted : March 4, 2014
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Pediatric Solid Tumors Refractory Pediatric Solid Tumors Tumors Located in Bone or Soft Tissue in Close Proximity to Bone Rhabdomyosarcoma Ewing Sarcoma Osteosarcoma Neuroblastoma Wilms Tumor Hepatic Tumor Germ Cell Tumor Desmoid Tumor||Device: Magnetic Resonance High Intensity Focused Ultrasound||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Feasibility Study of Using MR-guided High Intensity Focused Ultrasound (HIFU) for the Ablation of Relapsed or Refractory Pediatric Solid Tumors|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Magnetic Resonance High Intensity Focused Ultrasound (MR-HIFU) ablative therapy for children with recurrent or relapsed solid tumors.
Device: Magnetic Resonance High Intensity Focused Ultrasound
MR-High intensity focused ultrasound (HIFU) is an ultrasound based technology which allows for non-invasive thermal ablation of tumors under the guidance of MR thermography.
- Toxicity [ Time Frame: 28 days following ablative therapy ]Toxicity will be evaluated using CTCAEv4. Adverse events will be summarized descriptively with tabulations of adverse event type, severity, and relationship to study treatment.
- Disease response [ Time Frame: Up to 1 year ]We will preliminarily define tumor response from MR-HIFU ablative therapy assessed according to a modified Response Evaluation Criteria in Solid Tumors (RECIST). We will also evaluate functional tumor response using FDG-PET post MR-HIFU ablative treatment for patients with PET avid target lesions.
- Patient reported outcomes and quality of life measurements [ Time Frame: Up to 1 year ]We will use a validated symptom distress scale and quality of life metrics pre- and post-therapy at scheduled intervals.
- Immune Markers [ Time Frame: Pre-treatment, 1 day post treatment, 7 days post treatment ]Changes in immune markers from baseline and post therapy will be evaluated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076906
|Contact: Stephanie Forlenza, MAfirstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Emily Stern, RN, BSN 202-476-2802 email@example.com|
|Contact: Stephanie A Forlenza firstname.lastname@example.org|
|Principal Investigator: AeRang Kim, MD, PhD|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Laura Fossett 513-636-2799 email@example.com|
|Principal Investigator: James Geller, MD|
|Principal Investigator:||AeRang Kim, MD, PhD||Children's Research Institute|